A

PROJECT REPORT
ON
INDUSTRIAL TRAINING - I

[BP – 610P]

SUBMITTED

IN PARTIAL FULFILLMENT OF THE REQUIREMENTS OF THE AWARD

OF DEGREE
BACHELOR OF PHARMACY

BY
ROHIT PATEL
Roll No.- 2105750500075
B. Pharm IIIrd year (VIth semester)

Under the Guidance of

MRS. SHASHI DEVI (ASSOCIATE PROFESSOR)

MMT, CSM, GOI, FACULTY OF B. PHARMACY, IRADATGANJ, PRAYAGRAJ,

U.P.

DR. APJ ABDUL KALAM TECHNICAL UNIVERSITY,LUCKNOW, U.P.

(2023-24)
 CERTIFICATE

This is certify that Mr./ Mrs -.................................................... Roll no……………………………

of Malti Memorial Trust CSM Group of Institution Faculty of B- Pharmacy, Iradatganj,

Prayagraj has Successfully completed the industrial training Report ( BP610P ) project work

& viva - voce in partial fulfillment of requirement for the award of B. Pharma Degree

prescribed by the AKTU Lucknow.

Signature of Internal Examiner Signature of External Examiner

 CERTIFICATE BY THE GUIDE

Certified that ROHIT PATEL (Roll No. 2105750500075) B.Pharm 3rd Year, 6th Year has

carried out the training/project work on for the award of BACHELOR OF PHARMACY from DR.

APJ ABDUL KALAM TECHNICAL UNIVERSITY, LUCKNOW U.P. The

project/training work or carried out at VIBGYOR LABORATORY (INDIA) LTD., MEWALAL

BAGIYA, INDUSTRIAL AREA, NAINI, PRAYAGRAJ, U.P. By the student himself and the

contents of the project/training do not from the basic for the award of any other degree to the candidate

or to anybody else from this or any other University/Institution.

Date:
GUIDE:

Mrs. Shashi Devi

Place: (Associate Professor)
MMT. CSM. GOI.
Faculty of B. Pharmacy, Iradatganj, Prayagraj, U.P.
 ENDORSEMENT BY THE HEAD OF DEPARTMENT

This is to certify that ROHIT PATEL (Roll No. 2105750500075) B.Pharm 3rd year, 6th semester, 2023-

24, has submitted the report on Industrial training from VIBGYOR LABORATORY (INDIA) LTD.,

MEWALAL BAGIYA, INDUSTRIAL AREA, NAINI, PRAYAGRAJ, U.P. Under the supervision of MRS.

SHASHI DEVI (ASSOCIATE PROFESSOR), MMT. CSM. GOI. FACULTY OF B.

PHARMACY IRADATGANJ, PRAYAGRAJ, U.P. The contents of the project/training report do not form the

basis for the award of any other degree to the candidate or to anybody else from this or any other University/Institution.

Date DIRECTOR/PRINCIPAL

Place: MMT. CSM. Group of Institution

Faculty of B. Pharmacy Iradatganj, Prayagraj U.P.
 DECLARATION BY THE STUDENT

I hereby declare that this Project/Training is bonafide project/ training work carried out by me

from VIBGYOR LABORATORY (INDIA) LTD., MEWALAL BAGIYA, INDUSTRIAL

AREA, NAINI, PRAYAGRAJ, U.P. The contents of the project/ training donot from the basic for

the award of any other degree candidate or to anybody else from this or any other

University/Institution.

Date :

Place : ROHIT PATEL

 ACKNOWLEDGEMENT

I express my deeply involved gratitude for. The express my deep sensor and articulate my feeling

of gratitude to my PARENTS – MR. RAM NARAYAN PATEL & MRS. GUDIYA DEVI express

my deep sensor of gratitude and heartfelt thanks to my guide MRS. SHASHI DEVI (ASSOCIATE

PROFESSOR), MMT. CSM. GROUP OF INSTITUTION FACULTY OF B. PHARMACY

IRADATGANJ, PRAYAGRAJ, U.P. Who help me who heartedly throughout my work with his

excellent guidance.

I indeed indebted to his for incessant support, timely advice and constructive criticism that have

broughtthe successful of my task.

With joy the parent lave to trace,

Resemblance in his children’s face
And as hi forms their docile youth,
To walk the study paths of truth,
Observes them shooting in to men,
And lives in them life o’er again.”

I heartfelt thank to our institute teachers Mr. Brij Raj Singh, Mr. Suresh Chandra, Mr. R.K.

Keservani, Mr. Meenendra Tripathi, Mr. Rohit Keservani, Mr. Shashikant Tripathi for provided

are faculties and excellent guidance my sincere appreciation goes to my friend Anuj Sharma for their

help and cooperation in the presence study.

Date:
ROHIT PATEL

Place
 INDEX

S. NO. NAM PAGE NO.

E
Introduction
1 1

2 About Industry 2-12

4 Liquid oral 13-15

Master Formula
5 16-17

6 Liquid
18-21
Manufacturing

7 Capsule
22-26

8 Quality Control
27-32

9 Conclusion
33
 INTRODUCTION

VIBGYOR LABORATORIES INDIA was registered in 2010, VIBGYOR LABORATORIES has

made a name for itself in the list of top suppliers of pharmaceutical liquid oral and enzymes and
protein capsules in India. The supplier company is located in Prayagraj, Uttar Pradesh and is one
of the leading seller of listed products, VIBGYOR LABORATORIES is well known for the best
quality products and service from Prayagraj.

Company name : Vibgyor Laboratories,Pvt Ltd. India.

Address : Industrial colony, Naini, Prayagraj Uttar Pradesh. 211105.

1
 ABOUT INDUSTRY

VIBGYOR
VIBGYOR LABORATORY(INDIA) LIMITED

We introduce ourselves as an ethical, scientific based pharmaceutical company committed to

manufacturing and marketing "quality pharmaceutical formulations" in the Indian markets.
Vibgyor, a name that is symbolic of "SEVEN COLOURS PRESENT IN THE RAINBOW, was
established in 1970 and for over 50 years has established a strong presence through our dedicated
service.

At Vibgyor we accomplish our mission through our innovative products and strict quality
management system, which also reveals our commitment to quality and customer satisfaction.
Every day we are constantly focusing on our vision by manufacturing and marketing a range of
quality medicines at affordable prices so that we can keep our society glowing.

Laboratory has the patent of the cough syrup named as KOFGON. This is mainly used for the dry
cough.

Vibgyor laboratory has spread over 25000 square feet.

Mission

Honor our pledge to continuously improve and strive towards the highest quality standards in all
aspects of our business. Optimize the talents of our employees within a learning organization with
an environment that reward commitment, creativity, and performance. Value team work among
our employees, business associates, and customers as an integral factor in our continued business
success. Innovate continuously to develop new cutting-edge pharmaceutical and healthcare
technologies and products. Dedicate ourselves to total customer satisfaction in order to consistently
deliver outstanding value to our customers and stake holders.

2
Vision

Our vision is to become a technology-based Indian pharmaceutical company & to emergeoutas a

strong player in the domestic & international market. To keep improving the quality of life by
offering value-added novel products that are technologically innovative, cost effective and of
superior quality surpassing expections of customer across the globe.

THE BRAND

VIBGYOR LABORATORIES INDIA, a leading Indian Pharmaceutical company is a fully

integrated, 10 healthcare provider. With in-depth domain expertise in the field of healthcare, it has
strong capabilities across the spectrum of the pharmaceutical value chain. From formulations to
active pharmaceutical ingredients and animal healthcare products to wellness products, VIBGYOR
LABORATORIES has earned a reputation amongst Indian pharmaceutical companies for
providing comprehensive and complete healthcare solutions.

Formulations

Topical dosage form (cream Oral dosage forms (Tablets, hard and soft gel capsules) & Liquid orals
(syrup ointments) & Ophthalmic (eye/ear drops suspension)

ENVIRONMENT, HEALTH AND SAFETY (EHS) POLICY

VIBGYOR LABORATORIES is fully committed to and continuously endeavors to achieve

environment, health and safety excellence across all the units. The Company continues to invest
substantial resources towards sustaining and continuously improving the standard so environment,
occupational health and safety as it believes that its responsibility towards these Society and the
environment extends beyond those laid down by the regulatory authorities.

3
Pharmaceutical Industry in india - An Overview

The pharmaceutical industry in India was valued at an estimated US$42 billion in 2021. India is
the world's third largest provider of generic medicines by volume, with a 20% share of total global
pharmaceutical exports. It is also the largest vaccine supplier in the world by volume, accounting
for more than 50% of all vaccines manufactured in the world. With industry standards compliant
mega production capabilities and large number of skilled domestic workforce, Indian exports meet
the standards and requirements of highly regulated markets of USA, UK, European Union and
Canada

As of 2021, most of pharmaceuticals made in India are low cost generic drug which comprise most
of pharmaceutical export of India. Patented medicines are imported. APIs are imported from China
(60% supplies by volume worth US$2.4 billion) and Germany (US$1.6 billion) as well as from
US, Italy and Singapore.

OVER VIEW

As of 2002, over 20,000 registered drug-manufacturers in India sold $9 billion worth of

formulations and bulk drugs. 85% of these formulations were sold in India while over 60% of the
bulk drugs were exported, mostly to the United States and to Russia.

Most of the players in the market are small-to-medium enterprises; 250 of the largest companies
control 70% of the Indian market. Thanks to the 1970 Patent Act, multinationals represent only
35% of the market, down from 70% thirty years ago

Most pharma companies operating in India, even the multinationals, employ Indians almost
exclusively from the lowest ranks to high-level management.

Homegrown pharmaceuticals, like many other businesses in India, are often a mix of public and
private enterprise.

Government intervention
The Indian government established the Department of Biotechnology in 1986 under the Ministry
of Science and Technology, there have been a number of dispensations offered by both the central
government and various states to encourage the growth of the industry. India's science minister

4
launched a program that provides tax incentives and grants for biotech start-ups and firms seeking
to expand and establishes the Biotechnology Parks Society of India to support ten biotech parks
by 2010. Previously limited to rodents, animal testing was expanded to include large animals as
part of the minister's initiative.

The biotechnology sector faces some major challenges in its quest for growth. Chief among them
is a lack of funding, particularly for firms that are just starting out. The most likely sources of
funds are government grants and venture capital, which Incentives for R&D, product development
and high-value production

Government of India has launched a Production Linked Incentive (PLI) Scheme for
Pharmaceuticals with provision for disbursal of US$2 billion or INR 15,000 crore government
incentives, which will run from 2020-21 to 2028-29, to reduce import dependence, benefit
domestic manufacturers, boost product diversification and innovation for development of complex
and high-tech products especially in in vitro diagnostic devices and emerging technologies
especially in cell based or gene therapy, employment generation and production of wide range of
lower cost affordable medicines for consumers with the aim to achieve incremental sales of US$4
billion or INR 294,000 crore and incremental exports of US$2.7 billion or INR 196,000 crore
between 2022-23 to 2027-28.

Manufacture of API supplies in India

To eliminate the dependence on China after the 2017 China-India border standoff to foster an
Atmanirbhar Bharat, in July 2021 India's Council of Scientific and Industrial Research (CSIR)
initiated a Make in India program in collaboration with the coal and petroleum industries of India
to end-to-end manufacture 56 prioritised active pharmaceutical ingredient (API) for the In 2016-
17, China was the largest supplier of API to India with 66% share by volume of API raw material
supplies to India worth US$2.4 billion or INR 18,000 crore, followed by US$1.6 billion API
imported from Germany, the US, Italy and Singapore are other major suppliers to India.
h is a relatively young industry in India.

Foreign investment

Per India's Consolidated FDI Policy, 2020 (the "FDI Policy"), foreign direct investment ("FDI")
in the pharmaceutical sector in greenfield (new) projects is permitted up to 100% without the

5
approval of the Department of Pharmaceuticals (the "DOP"). In brownfield (existing) projects,
FDI exceeding 74% requires the investor to seek prior approval from the DoP in compliance with
the prescribed conditions under the FDI Policy.

Separately, FDI up to 100% is permitted for the manufacturing of medical devices for both
greenfield and brownfield projects without the approval of the DoP

An FDI approval from the DoP can be obtained within a period of ten to twelve weeks from the
date of the application, depending on the completeness of the documentation submitted by the
investor in support of the application, failing which, this timeline could vary.

6
 LIST OF MAJOR PHARMACEUTICAL COMPANY IN INDIA

Top listed pharmaceutical companies in India by market capitalization as of January 2022

Rank Company

1
Sun Pharma

2
Cipla

3
Divi’s Laboratories

4
Dr.. Reddy’s Laboratories

5
Gland Pharma

6
Torrent Pharma

7
Lupin

8
Alkem Laboratories

9
Cadila Healthcare

10
Aurobindo Pharma

7
 TYPES OF PHARMACEUTICAL DOSAGE FORM
they are marketed for use, with a specific mixture of active ingredients and inactive components
(excipients), in a particular configuration (such as a capsule shell, for example), and apportioned
into a particular dose.

Dosage forms (also called unit doses) are pharmaceutical drug products in the form in which
Depending on the method/route of administration, dosage forms come in several types. These
include many kinds of liquid, solid, and semisolid dosage forms. Common dosage forms include
pill, tablet, or capsule, drink or syrup, and natural or herbal form such as plant or food of sorts,
among many others.

Various dosage forms may exist for a single particular drug, since different medical conditions can
warrant different routes of administration.

as inhalational, buccal, sublingual, nasal, suppository or parenteral instead. Additionally, a specific

dosage form may be a requirement for certain kinds of drugs, as there may be issues with various
factors like chemical stability or pharmacokinetics.

1 Oral

2 Ophthalmic
3 Inhalation
3.1 Unintended ingredients

4 Injection
4.1 Unintended ingredients

4.1.1 Safe
4.1.2 Unsafe

5 Parenteral
6 Topical
6.1 Unintended use

8
7 Suppository

ORAL

Pill, i.e. Tablet or Capsule.

Syrups

Specialty tablet like buccal, sublingual, or orally-disintegrating

Thin film (e.g., Listerine Pocketpaks)

Liquid solution or suspension (e.g., drink or syrup)

Powder or liquid or solid crystals
Natural or herbal plant, seed, or food of sorts (e.g., marijuana such as that found in cannabis
edible)

Pastes (e.g., Toothpaste)

Buccal film

Ophthalmic

Liquid solution

A) Ophthalmic solutions 1. Eye drops 2. Eye lotions

B) Ophthalmic suspensions

C) Ophthalmic ointments
D) Ophthalmic emulsions

Inhalation

Aerosol
Inhaler

9
Nebulizer
Smoking
Vaporizer

Unintended ingredients

Tale is an Excipient often used in pharmaceutical tablets. Also, illicit drugs that occur as white
powder in their pure form are often cut with cheap tale. Natural Talc is cheap but contains
Asbestos while asbestos-free talc is more expensive. Inhaled talc that has asbestos is generally
accepted as being able to cause lung cancer if it is inhaled. The evidence about asbestos-free talc
is less clear, according to the American Cancer Society

Injection

Unintended ingredients

SAFE

Eye drops (normal saline in disposable packages) are distributed to syringe users by needle
exchange programs.

Unsafe

The injection of talc from crushed pills has been associated with talcosis in intravenous drug
users

Parenteral

Intradermal (ID)
Subcutaneous (SC)

10
Intramuscular (IM)
Intraosseous (10)
Intraperitoneal (IP)
Intravenous (IV)

Topical

Cream, gel, liniment or balm, lotion, or ointment, ete

Ear drops (otic)
Eye drops (ophthalmic)
Skin patch (transdermal)
Dermal patch
Powder/Talc

Unintended use

Medical transdermal patches. It is not safe to calculate divided doses by cutting and weighing
medical patches, because there's no guarantee that the substance is evenly distributed in the drug
reservoir

Fentanyl transdermal patches are designed to slowly release the substance over 3 days. It is well
known that cut fentanyl transdermal consumed orally have cause overdoses and deaths.

Single blotting papers for illicit drugs injected from solvents in syringes may also cause uneven
distribution in the drug reservoir.

Suppository

Intravaginal

11
Vaginal rings
Rectal
Urethral
Nasal
Drug delivery
Route of administration
Pharmaceutical packaging

12
 LIQUID ORAL

Introduction to liquid orals

Liquid orals are the pharmaceutical dosage form in liquid form to be administered orally either in
the form of solution, suspension, emulsion, elixir and many more.

Classification of Liquid Orals

Monophasic liquids
 Solution Elixir
 Syrup
 Liquid drops etc.
Biphasic liquids
 Suspensions
 Emulsions
SYRUP

Syrups are the concentrated dosage form syrups are the concentrated aqueous preparations of
sugar or sugar substitute with or without flavoring agents and medicinal substances,

13
Classification of syrup:

Medicated syrup: Contains therapeutic agents in it.eg, meperidine HCL

Non medicated syrup: Containing flavoring agents but not medicinal substances are called non
medicated or flavoured syrup.
Eg. Cocoa syrup
Orange syrup
Raspberry syrup

Advantage of syrup:
1. appropriate for any age group patient
2. appropriate easiest route of administration
4. no nursing is required which means the patient can take it with no help
3. economical and safe to the patient

Disadvantages:
1.delayed onset of action because absorption takes time
2. not suitable in emergency and for unconscious patient
3. Constipation ulceration and hyper acidity in stomach 4. cannot avoid first pass metabolism
Components of syrup
In addition to purified water syrup
1. sweetening agent
2. antimicrobial preservatives
3. flavouring agents
4. colorants

Types of syrup

14
1. Liquid Simple syrup: When purified water alone is used in the making of solution of sucrose
the preparation is known as syrup or simple syrup.

A. Simple syrup IP:

 Sucrose- 66.7 gram
 Purified water QS.
B. Simple syrup USP Sucrose-85 gram Purified water QS
2. Medicated syrup: when syrup contains medicinal substance is known as medicated syrup for
example cup syrup ginger syrup.
3. flavoured syrup: syrups containing flavouring agents but not medicinal substances are called
flavoured vehicles containing aromatic/flavoured syrup.
E.g. Cherry
Raspberry juice

15
 MASTER FORMULA

MASTER FORMULA RECORD

PRODUCT NAME- KOFGON SYRUP

GENERIC NAME- COUGH SYRUP
PHARMACOPOEIAL INDIAN PHARMACOPΡΟΕΙΑ
STATUS-
BATCH SIZE- 500 LTR
LABLE CLAIM- EACH 5 ML. CONTAINS:
Diphenhydramine HCI IP -10mg
Ammonium chloride IP-120mg
Sodium citrate IP-70mg
Menthol IP- Img
SHELF LIFE- 2 YEAR
STORAGE CONDITION: Keep it in a cool and dark place
Half tea spoon full thrice (children)
DIRECTION FOR USE: 1-2 Tea spoon full thrice (adult)
INDICATION- Cough in throat, temporarily treat cough, chest congestion, stuffy
. nose, symptoms caused by the common cold, flue,
CAUTION- To be taken under medical supervision
MANUFACTURED BY - VIBGYOR LABORATORY(INDIA)
MARKETED BY- VIBGYOR LABORATORY(INDIA)
STANDARD BATCH 500 LTR
SIZE-
MINIMUM BATCH 100 LTR
SIZE-
MAXIMUM BATCH 500 LTR
SIZE-

16
EQUIPMENT LIST- 1. STAINLESS STEEL CHARGE TANK/PAN
2. STAINLESS STEEL CHARGING TANK- 500 LTR
3. STAINLESS STEEL STIRRER
4. STAINLESS STEEL FILTER PRESS
5. STAINLESS STEEL STORAGE TANK
6. CAP SEALING MECHINE

17
 LIQUID MANUFACTURING

(KOFGON SYRUP)
RAW MATERIAL- There are following raw materials are used in the manufacturing of kofgon
syrup;
 Diphenhydramine HCI IP
 Ammonium chloride IP
 Sodium citrate IP
 Menthol IP

EQUIPMENT-
1. STAINLESS STEEL CHARGE TANK/PAN
2. STAINLESS STEEL CHARGING TANK-500 LTR
3. STAINLESS STEEL STIRRER
4. STAINLESS STEEL FILTER PRESS
5. STAINLESS STEEL STORAGE TANK
6. CAP SEALING MECHINE

MANUFACTURING OF KOFGON SYRUP

Prepare syrup with 40 kg sugar in 20 ltr of boiling purified water. If the sugar syrup is coloured,
0.1% citric acid is to be added gradually in the sugar syrup and scrap from the surface of the
liquid to be removed.

SOP FOR MIXING OF 500 LTR KOFGON SYRUP

 Take 40 kg of sugar in ss tank

 Take 5 ltr of RO water and add 7.7 kg of sodium citrate and dissolve it till it gets
 completely dissolved Dissolve 13.2 kg of ammonium citrate in 20 ltrs of RO water in
separate vessel at room temperature
 Add solution in previously processed solution in sugar tank and stir it

18
  Make a solution of 50 gm of citric acid and adjust the pH of the base as required Then
add ammonium chloride and sodium citrate solution in the syrup tank in stirring
condition
 Dissolve 1.1 kg of diphenhydramine HCL in a separate vessel and add it slowly to
house tank by slow stirring Crush menthol into very fine powder
 Add the solution in finely powdered menthol in base tank Add 20 gm of caramel colour
to the base tank
 Add 750 ml of raspberry ascents to the syrup tank Make the volume to 500 Itr and stir it
for atleast 3 hours
 Keep the batch under observation after proper cooling of solution send it for filtration

SOP FOR FILTRATION

 Sparkler filter system is washed with hot RO water and dried

 Inlet and outlet tubes are autoclaved
 Dry filter pads are allowed to set in the system and get it covered with sealed jacket The
solution is passed through the filter system and is collected in a separate cover ss tank
 SOP FOR BOTTLE FILLING
 Filling machine is being calibrated in accordance with the required unit
 All connection part of filling machine washed with hot RO water
 At the time when filling is started the volume of the solution is checked at every 10
 minutes interval and accordingly adjusted
 In continuation the filled bottles are capped and checked visually
 The solution filled in the bottle is visually checked and sealed
 Bottles are now sent to the packing quarantine

SOP FOR BOTTLE PACKING

All the filled bottles are rubbed with a cloth to avoid the moisture of the bottle Bottles are
labelled, packed in a carton box with a required name, batch number, manufacturing and expiry
date accordingly

19
SOP FOR RELEASE AND DISPATCH
Prior to release of packed goods for quality control confirms the release order Dispatch is being
as per order

SOP FOR PACKING MATERIALS

BOTTLES

1. Average 100 ml ambered colored bottle measurement is as follows-

A.25 mm diameter of neck
B. 11.5 cm of height
C. 4.5 cm bottom diameter

2. Average 450 ml ambered color bottle measurement as follows

A.25 mm diameter of neck
B. 17.5 cm height
C. 6.00 cm bottom diameter
D. pH =neutral

LABEL

A. 4 color printing on mirror coat paper or 120 GSM

C. 6 cm width
B. 11.5 cm in height

SIDE EFFECT OF COUGH SYRUP

Drowsiness, dizziness, blurred vision, nausea, vomiting, trouble sleeping, or headache

may occur. If any of these effects last or get worse, tell your doctor or pharmacist
promptly.

If your doctor has directed you to use this medication, remember that your doctor has
judged that the benefit to you is greater than the risk of side effects. Many people using
this medication do not have serious side effects.

20
IIIII II IIIIII IIIII

21
 CAPSULE
Definition

Capsules are solid dosage forms in which the drug or a mixture of drugs with or without
excipients is enclosed in Hard Gelatin Capsule Shells, in soft, soluble shells of gelatin, or in hard
or soft shells of any other suitable material, of various shapes and capacities. They usually
contain a single dose of active ingredient(s) and are intended for oral administration.

Advantages
 The drugs having unpleasant odour and taste can be administered by enclosing them in a
 tasteless shell.
 They are smooth, become very slippery when moist and can be easily swallowed.
 They are economical
 They are easy to handle and carry.
 The capsules release the medicament as and when desired in gastro-intestinal tract.

Disadvantages
 Capsule should not used for highly efflorescent material as material may cause the
capsule to soften by losing water molecule to shell,
 Capsule should not used for highly deliquescent powder as powder have tendency
to absorb moisture from capsule shell & make it brittleness.
 The capsule shells can absorb water from the environment and develop problems
with
 drug stability and capsule shell can become tacky
 it unsuitable for use with liquid formulations

TYPES OF CAPSULS 

1. Hard Gelatin capsule [HGC]

2. Soft Gelatin capsule [SGC]

22
Hard gelatin capsule
Hard Gelatin capsule it is the capsule in which medicament(s) with or without excipient
in the dry powder form are enclosed in a shell which consist of cap & body.

Advantages
 Protection of filling.
 Masking effect.
 Various types of filling.
 Enhanced distinguishability.
Disadvantages
 Less durable. Capsules tend to be less stable than tablets ..... Shorter shelf life.
Capsules expire more quickly than tablets
 More expensive. Capsules that contain liquids are generally more expensive to
manufacture than tablets and may cost more as a result.
 May contain animal products.....
 Lower doses.

Soft gelatin capsule

A soft gelatin capsule is a type of capsule that is usually used to contain medicine in the
form of liquid or powder, and which dissolves more quickly than hard gelatin capsule.

Advantages
 protection of APIs.
 improved swallowability.
 the ability to readily dissolve in the gastric juices of the gastrointestinal tract.
Disadvantages
 Soft gelatin capsules having difficulties in dealing with water soluble materials.
 Soft gelatin capsules are highly sensitive to moisture.
 Soft gelatin capsules having difficulties in dealing with efflorescent materials.
 Soft gelatin capsules having difficulties in dealing with deliquescent materials.
 As gelatin is obtained from animal source so soft gelatin capsules are not suitable
for people belongs to vegetarian group.

23
 CAPSULE MANUFACTURING

Raw material for lycopine capsule

Lycopene capsule is used as a health supplement and an adjuvant therapy that contains
effective formulation such as Lycopene, Lutein, DL-Methionine, Adenosylcobalamin and Grape
Seed Extract Soft Gelatin Capsules.
These all compositions are the perfect healthy combination of powerful antioxidants,
vitamins, and minerals which help to improve health and maintain important body functions.

EQUIPMENT

Hand filling machine

 It consist of a bed having 200-300 hole, a loading tray having 200-300 holes, a
powder tray, a pin plate having 200-300 pins, a sealing plate having a rubber top,
a lever, a cam handle.
 The empty capsules are filled in the loading tray and it is palced over the bed. The
cam handle is operated to separate the capsule caps from their bodies.
 The powder tray is placed in a proper position and filled with an accurate quantity
of powder with scraper. The excess of the powder is collected on the platform of
the powder tray. The pin plate is lowered and the filled powder is pressed by
moving the pin downwards.
 After pressing the pin plate is raised and the remaining powder is filled into the
bodies of the capsules. The powdered tray is removed after its complete filling.
The cap holding tray is again placed in position. The plate with the rubber top is
lowered and the lever is operated to lock the caps and bodies. The loading tray is
then removed and filled capsules are collected.

MANUFACTURING PROCESS OF CAPSULE

 Place empty capsules onto the loading tray and place tray onto the machine.
Check the front knob it should be turned to the right.

24
 Pull locking lever forward. Push down long handle which will lifts the caps off all
the bodies. Set aside the tray containing all the caps.

 Push locking lever back, by which capsule bodies will drop down and become
level with filling surface.

 Place powder tray on filler. keeps powder from spilling.

 Pour & spread the pre-measured powder. Move extra powder onto powder tray's
shelf. Lower tamper and lock.

 Turn handle to compress powder: this allows you to fill more powder in each
capsule.

 Raise tamper & spread extra powder from shelf into capsules: ensures uniform fill
weights.

 Return the tray containing caps to filler. Turn front knob to the left and lower
locking plate. Engage lock for locking plate.

 Hold tamper handle and push down on long handle. Bodies are pushed up into
caps: all the capsules are now locked in one step.

 Disengage lock for locking plate. Lift locking plate and turn front knob to the
right.

 Push down long handle and remove tray of completed capsules.

 Capsules are filled now. You can turn tray and all the capsules will get out from
the tray.

25
 USES OF LYCOPINE CAPSULE

uses include for cancer, preventing atherosclerosis, cardiovascular disease, prostate

cancer, human papillomavirus (HPV) infection, cataracts, asthma, antioxidant, and as an anti-
inflammatary.

Lycopene is LIKELY SAFE when taken by mouth in appropriate quantities. Daily

supplements containing up to 120 mg lycopene have been used safely for up to one year. No such
side effects have been reported.

26
 QUALITY CONTROL

The concept of quality control refers to the process starving to produce a perfect product by a
series of measures requiring an organized effort at every stage in production.
Quality Control ensures product stability keeping the compliance to GMP going and assures that
product will retain all there claim till they are consumed. The sample should be inspected for
defects which could affect the performance or stability of the product.

Functions of quality control are:-

1. To prepare the detailed instructions for each test and analysis.
2. To release or reject
 Each batch of raw material
 Semi finished/finished products
 Packing & labeling material
3. To evaluate the conditions under goods are store.
4. To evaluate the quality & stability of product.
5. To establish and revise control procedure and specifications.

Procedure for Quality Control: Step involved are:-

1. Raw Material Analysis: - After recording raw material in store division in store division
quality control dept is called for sampling for testing its quality and purity as per
pharmacopoeias. Where the raw material stand in its quality. The quality control passes the raw
material for production. For inspection two sample from each of tablet, capsule and liquid
section are selected. One is meant for testing and another one is for storage. As the sample
reaches the quality control lab, it is recorded in the SAS register and a sampling slip is put in the
sample.
2. In Process Control: There is a real and significant difference between a finished product
compounding standard and the manufacturingFor quality assurance the sample size usually taken
as:-
A. 40 Tablet (min.)
B. 2 Liquid preparation (sealed) C. 2 Sterilized preparation (sealed)
D. 40 Capsules
E. 2 Powder preparations (packed)

27
Under in process control the sample is collected from immediately processed bulk, The process
of sending sample to quality control is very burdensome. So in order to case this process,
convenient equipment is available in the mfg. dept. near to the site or activity.

1. Electronic balance for testing weight variation.

2. Hardness tester (Tablets)
3. Measuring Cylinder - To measure volume of liquid preparation.
4. Inspection chamber-To inspect antiforeigner particle or turbidity in solution.
5. D.T. Machine
6. Friabilator

The immediate recording of result is made in register is made in register with other information
e.g. name of the product, Batch No., Date, time etc. process.

Method used to check the quality

1. Electronic method
2. Solvent Extraction Method
3. Spectrophotometer Method
4. Chromatographic Method

Program adopted for observing GMP and to build quality of the product
There are many tests that are used for quality assurance of various formulations as:-

(A) For Tablets

From manufacturing batch of tablets 30-40 tablets are sent Q.C. to test them for-

1. Weight Variation: A tablet must contain the proper amount of drugs. For testing weight
variation a sample of 10 tablets are taken hourly and weighted on electronic or physical balance.
The tablets must have acceptable average weight.

28
2. Friability Testing: This is an internal standard test. This test is essentials for consumer
acceptance. Tablets require certain amount of strength to withstand mechanism shocks on
handling packing, and shipping.

3. Hardness testing:- Hardness testing determines the cursing strength of tablets. To check the
hardness the tablet is placed between two finger of tester both horizontally and vertically and
force is applied. The hardness of tablet must not be less than 4 kg, and not more than 6 kg.

4. Disintegration time: This is the time on which breakdown of tablet in GIT occurs. To test
D.T. a disintegration test apparatus is used that is set as per pharmacopeias. Starch paste is
employed as disintegrating agent who may draw water in to the tablet, causing tablet to swell and
burst apart. There are internal standards for D.T. i.e. 15minutes. If tablet disintegrates within 10
minutes then the batch of tablet is contained otherwise batch is cancelled.

5. Dissolution time: As the tablet break down in small particles it should offer a grater surface
area to the dissolved media. Dissolution apparatus is a 8 paddled machine and temperature, speed
and time can be adjusted.
6. Strip leakage test: - To test whether the strips are leak-proof or not.

(B) For Capsules

1. Weight Variation: A sample of 10 tablets is hourly taken and average weight is taken. Then
each capsule is weighted individually and compared with average weight.
Not content less then 300mg Not content more then 300mg 7.5 10%
2. Dissolution time: Same as for tablet
3. Disintegration time: Same as for tablets

(C) Sterile Preparation

1. Clarity test
2. Sterility test

29
RECORD MAINTENANCE IN Q.C.:-

For record maintenance in Q.C. there are separate recording registers, having columns for the
name, batch No, date & result for the product being analyzed e.g.:-
 One register for in process control analysis
 One register for raw material analysis
 One register for finished and packed product analysis

Daily entry is made to avoid any error. A part form this, for incoming of reagent in Q.C. another
record is maintained.

MICROBIOLOGICAL ANALYSIS: It include following instruments-

 Hot air oven

 Autoclave
 Incubator
 Aseptic room

30
Vibgyor Manufacturing section

31
During Training Memories

32
 CONCLUSION

Thus at the end I have reach at conclusion that during my one month training in VIBGYOR
LABORATORIES (INDIA) I have understand the environment of industry and how much
company's staff do the hard work in the production of such a bulk number of product and how
one can cope with the problem while working. A pharmaceutical manufacturing unit is placed
where not only been best possible formulation are prepared to serve the social surrounding but
also industrial training program carried out to prepare technically skilled manufacturing chemist
and analysts
In this industry both the above two functions are carried out under the supervision of well skilled
experienced and technical persons with complete attention and honesty that improves not only
the growth profile of industry but also produce best chemist and analysts in future
I wish for a sharp growth profile of the industry in the coming days and I also admire it to be one
of the best places for producing better chemists and analysts beyond the formulation
My opinion about industry is best places are occasionally been noted by someone this is one of
them noted by me
I like the environment, staffs and head of departments and heartily wish to work with them ever when an
opportunity is given to me

33